Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

NCT ID: NCT05150275

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route.

The aim of the research is to analyze postoperative pain

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hysterotomy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hysterotomy vNOTES Laparoscopy Vaginal route

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult woman (≥18 years old)
* Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
* Woman who did not express her opposition to the reuse of her data for the purposes of this research.

Exclusion Criteria

* Woman who expressed her opposition to participating in the study
* Surgical procedure associated with hysterectomy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olivier GARBIN, MD

Role: PRINCIPAL_INVESTIGATOR

Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivier GARBIN, MD

Role: CONTACT

Phone: 33 3 69 55 34 04

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olivier GARBIN, MD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8418

Identifier Type: -

Identifier Source: org_study_id